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KMID : 0390320150250010021
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Chungbuk Medical Journal
2015 Volume.25 No. 1 p.21 ~ p.27
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Performance Evaluation of HbA1CHA-8180 and glucose GA-1171 Analyzers for Consecutive Assay of HbA1C and Glucose in EDTA Specimen
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Son Bo-Ra
Shin Kyeong-Seob
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Abstract
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Purpose: Both blood glucose and hemoglobin A1C (HbA1C) concentrations are frequently measured to monitor the control of blood glucose concentration in diabetic patients. We evaluated the analytical performance of ADAMS bridge system (ARKRAY, Inc., Japan) consisting of the ADAMS HbA1CHA-8180 and the ADAMS glucose GA-1171 analyzers, which allows the consecutive analysis of HbA1C and glucose from EDTA whole blood.
Materials and Methods: We examined precision, linearity, carry-over, and verification of reference interval. Comparison study were conducted between HA-8180 and Bio-Rad Variant II Turbo (Bio-Rad, Inc., USA) for HbA1C measurements, and GA-1171 and Hitachi 7600 chemical analyzer (Hitachi, Inc., Japan) for blood glucose.
Results: Total precision (% CV) in measuring high and low level controls was 0.465% and 1.40% for HbA1C using HA-8180, and 1.55% and 2.08% for glucose using GA-1171 respectively. In the linearity test, R² was 0.9999 and 0.9987 when measuring HbA1C (4.4-14.2%) and whole blood glucose concentrations (57-490 mg/dL), respectively. Good correlation was observed between HA-8180 and Variant II Turbo (r=0.9959), and GA-1171 and Hitachi 7600 (r=0.9930). Moreover, the correlation of glucose between whole blood and plasma by GA-1171 was excellent (r=0.9952). Carry-over effect was
0.0% for HbA1C and blood glucose.
Conclusions: The performance of HA-8180 and GA-1171 analyzer, including precision, linearity and comparison study, were excellent. Moreover, the ADAMS bridge system had a simple procedure for sample processing and rapid turnaround time. Therefore, the routine application of this analyzer to monitor HbA1C and glucose in diabetes patient may be useful in the clinical laboratory.
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KEYWORD
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ADAMS bridge system, HA-8180 analyzer, GA-1171 analyzer, HbA1C, Evaluation
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